PMA P110042S058
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S058
- Product code
- LWS
- Decision date
- 2016-08-08
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for the Model A219 EMBLEM MRI S-ICD as well as modifications to the Model A209 EMBLEM S-ICD, Model 3401 EMBLEM S-ICD Subcutaneous Electrode, Model 4711 EMBLEM S-ICD Subcutaneous Electrode Insertion Tool, Model 2877 Programmer Software Application and Model 3200 EMBLEM S-ICD Programmer.
Current openFDA PMA Record#
- Device
- SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S058
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2016-08-08
- Decision code
- APPR
- Date received
- 2016-02-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Model A219 EMBLEM MRI S-ICD as well as modifications to the Model A209 EMBLEM S-ICD, Model 3401 EMBLEM S-ICD Subcutaneous Electrode, Model 4711 EMBLEM S-ICD Subcutaneous Electrode Insertion Tool, Model 2877 Programmer Software Application and Model 3200 EMBLEM S-ICD Programmer.